DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in response to papers filed 4/27/2026.
Applicant’s election of Group I and the species of Gln33STOP in the reply filed on 9/16/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9, 48-52,and 78 are pending. Claims 10-47 and 53-77 have been cancelled.
Claims 48-52 have been withdrawn as being drawn to a nonelected invention.
The following rejections are newly applied or modified as necessitated by amendments. Response to arguetmsn follows.
This action is FINAL.
Newly Applied Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-9 and 78 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly recited limitations of “the therapeutic agent is not an antibody and the TYROBP agonist is a TREM2 protein” in claim 4 is considered new matter. The newly applied claim 78 wherein the method comprises “administering a TREM2 agonist and a TRYOBP agonist” is considered new matter. The reply provides that the claims have been described on page 14 lines 20-21, page 24-29 and p. 16 bottom two paragraphs.
On page 14, the specification teaches that “TYROBP agonist” can be administered. Page 16 of the specification teaches that the TREM2 agonist is a TREM2 activating antibody or small molecule”. Further the specification teaches that “TYROB agnostic is a TREM2 protein”. However, the specification does not teach that the “the therapeutic agent is not an antibody and the TRYOBP agonist is a TREM2 protein”. There is no indication that the protein recited is “not an antibody”. It is noted that the only recitation of antibody in the specification is on page 16 that states “TREM2 agonist is a TREM2 activating antibody”. As such the specification has not described sufficient structure of TYROBP agonist being a TREM2 protein and the exclusion of antibodies.
Although page 16 recites that TREM2 agonist and TYROBP agonist on page 16, the specification does not teach the recited limitation in claim 78 that both are administered.
Modified Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4-9 are indefinite over “when the subject is TREM2 reference” in claim 4 and 5. This phrase is unclear as it is not clear the metes and bounds of “TREM2 reference” as it is not clear how “TREM2 reference” correlates to the determining TREM2 variant.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following. The reply asserts that the specification provides genetic alterations that change in the human TREM2 reference (see SEQ ID Num 1) (p. 7). This arguetmsn has been fully reviewed but have not been found persuasive. The recitation in the specificaoin is not a limiting definition of “TREM2 reference”. Although one embodiment of the reference is a comparison to SEQ ID No. 1, the term can be broadly applied to any fragment considered TREM2. Therefore the rejection had been maintained.
Modified or Newly Applied Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Modified Claim(s) 1-3 and 78 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schware et al. (WO2017/062672 April 13, 2017).
With regard to claim 1, Schware et al. teaches administering an TREM2 agonist which would be considered a TREM2 protein to a subject with Alzheimer’s disease (para 14-16).
With regard to Claim 2, Schware et al. teaches that the subject can have a mutation that leads to loss of function (para 14).
With regard to claim 3, Schware et al. teaches a start loss variant (para 48)
With regard to claim 78, Schware et al. teaches a TREM2 agonist and as provided by the instant specificaoin on page 16, the TREM2 agonist would be considered a TYROBP agonist. One embodiment of the claim is the administration is considered one agonist.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following. The reply asserts that the claims are limited to a protein that is “not an antibody”. However it is noted that claim 1 is not limited to a protein that is “not an antibody”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schware et al. (WO2017/062672 April 13, 2017 previously recited ) in view of Culp et al. (US Patent Application Publication 2019/0040131 Feb 7, 2019).
With regard to claim 4-6, Schware et al. teaches administering an TREM2 agonist to a subject with Alzheimer’s disease (para 14-16). Schware et al. teaches determining that the subject has a TREM2 variant genotype (para 48). Schware et al. teaches to continue to administer treatment to patients with heterozygous variant of TREM2 with a TREM2 agonist (para 48, 413-415). It is noted that it is not clear the mete of TREM2 reference and as such it is interpreted as encompassing a variant of TREM2. However TREM2 taught is not a protein that is not an antibody.
With regard to claims 7-9, Schware et al. teaches detection of Gln33STP which would be the nucleic acids that encompass 6:41161557G:A (para 48). As Schware et al. teaches the same variant the variant as encompassed by Schware et al. would encompassed the claimed cDNA structure.
With regard to claim 4, Culp et al. teaches one can treat with a TREM2 protein (para 389).
Therefore it would be prima facie obvious to the ordinary artisan at the time of the effective filing to modify Schware et al. to use any treatment associated with TREM2 including the treatment of Culp et al. The ordinary artisan would have a reasonable expectation as Culp et teaches that one can treat with the protein.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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